An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants

Healthy Participants Clinical Trial

Official title:

A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BMS-986259 in Healthy Participants.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008992
• Other study ID #: CV019-002
• Status: Completed
• Phase: Phase 1
• Start date: June 18, 2019
• Est. completion date: January 4, 2021

Study information

• Verified date: April 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 4, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy participants with a body mass Index (BMI) of 18.0 kg/m^2 - 30.0 kg/m^2.

• Males and females not of child bearing potential.

• Participants in the Japanese Cohorts in Part C must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese.)

Exclusion Criteria:

• Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study.

• Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months.

• Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986259
Single and Multiple ascending dose from Dose 1 to Dose 5

Other:
• Placebo
Placebo matching BMS-986259

Diagnostic Test:
• P-Aminohippurate
Diagnostic Agent
• Iohexol
Diagnostic Agent

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences - Groningen	Groningen
United Kingdom	Richmond Pharmacology	London

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 7 weeks
Primary	Incidence of Serious Adverse Events (SAEs)		up to 7 weeks
Primary	AEs leading to discontinuation		Up to 7 weeks
Primary	Number of clinically significant changes in vital signs		Up to 7 weeks
Primary	Number of clinically significant changes in ECG (electrocardiogram)		Up to 7 weeks
Primary	Number of clinically significant changes in physical examinations		Up to 7 weeks
Primary	Number of clinically significant changes in clinical laboratory tests		Up to 7 weeks
Secondary	Maximum observed concentration(Cmax)- Part A SAD		up to 7 weeks
Secondary	Time of maximum observed concentration(Tmax)- Part A SAD		Up to 7 weeks
Secondary	Terminal elimination rate constant (Lz)-Part A SAD		up to 7 weeks
Secondary	Half life (T-HALF)- Part A SAD		Up to 7 weeks
Secondary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD		Up to 7 weeks
Secondary	Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD		Up to 7 weeks
Secondary	Apparent total body clearance(CL/F)-Part A SAD		Up to 7 weeks
Secondary	Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD		Up to 7 weeks
Secondary	Maximum observed concentration(Cmax)-Part B and Part C MAD	For day 1 , day 13 and day 14	Up to 7 years
Secondary	Time of maximum observed concentration(Tmax)-Part B and Part C MAD	For day 1, day 13 and day 14	Up tp 7 weeks
Secondary	Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD	For day 1 and day 14	Up to 7 weeks
Secondary	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)-Part B and Part C MAD	For Day 14	Up to 7 weeks
Secondary	Terminal elimination rate constant (Lz)-Part B and Part C MAD	For day 14	up to 7 weeks
Secondary	Half life (T-HALF)- Part B and Part C MAD	For day 14	Up to 7 weeks
Secondary	Apparent total body clearance(CL/F)-Part B and Part C MAD	For day 14	Up to 7 weeks
Secondary	Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD	For day 14	Up to 7 weeks
Secondary	Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD	For day 14	Up to 7 weeks
Secondary	Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD	for day 14	Up to 7 weeks

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls